Priority review from FDA for new BLA for sotatercept, an activin signaling inhibitor, to treat adults with pulmonary arterial hypertension

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of March 26, 2024.

PAH is a rare, progressive and ultimately life-threatening disease characterized by the narrowing of blood vessels in the lungs, causing significant strain on the heart. The application for sotatercept is based on data from the Phase III STELLAR trial, in which sotatercept on top of background therapy demonstrated a statistically significant and clinically meaningful improvement in 6-minute walk distance (6MWD) and eight of nine secondary outcome measures. These results were presented at ACC.23/WCC and published in The New England Journal of Medicine (previously cited).

“Despite advances in the treatment of PAH over the last two decades, there is still a significant need to improve outcomes for patients,” said Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. “The FDA’s acceptance of this application is an exciting milestone in our journey to bring this novel activin signaling inhibitor to patients. Based on the profound improvements across primary and secondary outcome measures in the Phase III STELLAR trial, we believe sotatercept has the potential to transform the treatment of patients with PAH. We look forward to working closely with the FDA to bring sotatercept to patients in need.”